PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

A Phase III, Multicentre, Randomized, Double-blind Clinical Study, Investigating the Efficacy and Safety of Repeated 12-week Courses of Daily 5mg or 10mg Doses of PGL4001 for the Long-term Management of Symptomatic Uterine Fibroids

Phase III, multicentre, randomized, double-blind, parallel group, long-term study investigating the efficacy and safety of the 5mg and 10mg doses of PGL4001 for the treatment of uterine myoma.

The target population is composed of pre-menopausal women with symptomatic uterine myoma(s) characterised by heavy bleeding.The main objective of this study is to assess the sustained efficacy and safety of long term on-off treatment with PGL4001 5 or 10mg doses on uterine bleeding, myoma size, pain and quality of life.

Inclusion Criteria:

• Be a pre-menopausal woman between 18 and 50 years inclusive.
• Have a Body Mass Index (BMI) ≥ 18 and ≤ 40.
• Have FSH levels ≤ 20 mIU/mL
• Have excessive uterine bleeding due to myoma.
• Have regular menstrual cycles
• Have a myomatous uterus < 16 weeks with at least one myoma ≥ 3 cm in diameter.
• If of childbearing potential the subject must be practicing a non-hormonal method of contraception.

Exclusion Criteria:

• Has a history of or current uterine, cervical, ovarian or breast cancer.
• Has a history of or current endometrium atypical hyperplasia or adenocarcinoma.
• Has a known severe coagulation disorder.
• Has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM).
• Has abnormal hepatic function at study entry.
• Has a positive pregnancy test, is nursing or planning a pregnancy during the course of the study.
• Has a current (within twelve months) problem with alcohol or drug abuse.
• Is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.